An Interventional Study to Evaluate the Impact of Blood Flow Restriction Training on Muscle, Bone, and Quality of Life in Adults With Osteogenesis Imperfecta Type I
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood flow restriction training.
- Who it may be relevant to
- Registry conditions: Osteogenesis Imperfecta, Type I. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Background: Due to fear of injury and risk of fractures, many people with osteogenesis imperfecta (OI) avoid vigorous exercise that is likely to improve muscle and bone weakness common in this disorder. Low-intensity muscle strength training with blood flow restriction (BFR-LI) via an inflatable cuff leads to similar improvements in muscle size and strength to conventional high-intensity strength training but has not been applied in OI.Objectives: To evaluate the effect of BFR-LI on muscle and bone health and quality of life in adults with OI type I.Methods: For this randomized controlled trial, 40 adults (18-65y) with OI type I will be recruited. Exclusion criteria include pregnancy or \<6 months postpartum, deep vein thrombosis, acute fractures, recent surgery, regular vigorous exercise, or contraindications to exercise. Participants will be randomly assigned to perform BFR-LI or standard care. The BFR-LI group will perform home-based exercises 2-3 times/week for 12 weeks at low training intensity (20% of 1-repetition maximum) which will increase every 4 weeks. Muscle and bone parameters will be evaluated using scans (peripheral computed tomography and dual-energy x-ray absorptiometry) and muscle strength tests, and quality of life (mental well-being, participation, pain and fatigue) by the PROMIS questionnaire at baseline, immediately, three, and six months after training.
Interventions
- Other Blood flow restriction training
The validated Smartcuffs PRO will be used. Maximal occlusion pressure (MOP), i.e., the pressure needed to fully occlude blood flow in the limb, is determined using a pulse pressor sensor while lying. 80% of the MOP is used for the training, achieving partial arterial occlusion and total venous occlusion. Resistance exercises (squats, hamstring curls, toe stands) are performed at 20% 1RM and in 4 sets (1x30, 1x15, 1x15, and 1x until failure). Participants will perform the 12-week training program
Primary outcome measures
- Muscle mass [Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))]
Secondary outcome measures (8)
- Other muscle parameters: muscle strength measurements [Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))]
- Other muscle parameters: muscle strength measurements [Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))]
- Other muscle parameters: muscle strength measurements [Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))]
- Bone parameters [Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))]
- Bone parameters [Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))]
- Bone parameters [Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))]
- Bone parameters [Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))]
- Quality of life [Time frame: Will be evaluated four times (at baseline, immediately, three, and six months after training (intervention group)/ 12 weeks of standard care (control group))]
Eligibility criteria
Inclusion criteria
- Osteogenesis imperfecta type I, aged between 18 and 65 years old
Exclusion criteria
- Lower limbs:
Edema; Recent surgery; Acute fractures
- Pregnancy/<6 months postpartum
- Deep vein thrombosis (now or history of)
- Cardiovascular, respiratory, or neuromuscular diseases
- Recent cardiovascular events/untreated hypertension
- Diseases affecting vascular function (e.g., diabetes)
- Vigorous strength training in year before study
- Other contraindications to perform exercise
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Ghent University (Hospital) - department of endocrinology and department of rehabilitation — Ghent
Identifiers
NCT: NCT07478224 · ONZ-2024-0333